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Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
QLM3003
QLM3003 Placebo
Sponsored by
Qilu Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy adult subjects between 18-55 years of age (inclusive), male or female The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight not less than or equal to 50 kg, females of weight not less than or equal to 45 kg. Subjects have no sperm donation, egg donation plan, no pregnancy plan and voluntarily take effective contraceptive measures from 14 days before signing the informed consent form to 30 days after the last dose of investigational product; The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form. Exclusion Criteria: Patients who are allergic to the investigational product or its preparation ingredients, or have previous allergic diseases, history of drug allergy, history of skin allergy, or known to be hypersensitive; Patients with clinically relevant skin diseases that are contraindicated in the study or affect the assessment of the administration site at screening, including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, or other skin lesions, and a history of skin cancer; Skin conditions affecting the assessment of the study drug such as ulceration, injury, sunburn, redness and swelling, rash, or abnormal fever, tattoos, birthmarks, skin scars, skin perforations, skin infections on the skin of the target application area at screening and before administration, or disagreeing to removing the hair on the skin of this site; Pregnant or lactating women, and those who cannot use one or more non-drug contraceptive measures during the trial; Patients who have difficulty in collecting blood or cannot tolerate venipuncture, and have a history of fainting needle halo; Those who have special requirements for diet and cannot abide by the unified diet; Excessive consumption of tea, coffee or caffeinated beverages, or consumption of grapefruit, or xanthine-rich foods or beverages within 14 days before screening, or inability to stop consumption of xanthine-rich foods or beverages, or grapefruit or pomelo and products containing grapefruit or pomelo ingredients within 48 hours before dosing and during the trial; Patients who smoked more than 5 cigarettes or the same amount of tobacco daily for 3 months before screening and could not stop using any tobacco products during the trial; Regular drinkers within 6 months before screening, i.e., those who drank more than 14 units of alcohol per week or could not stop using any alcohol-containing products during the trial; or those who took any alcohol-containing products within 48 hours before the first dose, or those who tested positive for alcohol breath before randomization; Drug abusers or those who have used soft drugs within 3 months before screening or hard drugs within 1 year before screening or those who have positive drug abuse screening before randomization; Blood donation or massive blood loss, receiving blood transfusion or using blood products within 3 months before screening; Any surgical procedure within 30 days prior to Screening or planned during the study and within 30 days after the end of the study; Patients who have received any live vaccines within 30 days before screening or need to receive live vaccines during the study; Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days before screening; Patients who have taken any drug or health product within 14 days before screening; Patients who have participated in and used any drug or medical device clinical trials within 3 months before screening, or within 5 half-lives of other investigational drugs before screening; Patients with previous serious or clinically significant diseases or abnormalities at screening, including but not limited to cardiovascular system, nervous system, respiratory system, blood and lymphatic system, digestive system, immune system, liver, kidney, metabolism and bone system diseases or psychiatric diseases or history of malignant tumors; Abnormal vital signs or clinically significant abnormalities in physical examination, ECG and laboratory tests (subject to the judgment of the clinical study physician); Patients with active tuberculosis suggested by clinical symptoms, signs, laboratory tests or chest radiography at screening; Patients whose white blood cell count, neutrophil count, lymphocyte count or hemoglobin in blood routine examination exceed the normal reference range and have clinical significance judged by the investigator; May increase study-related risks, may interfere with interpretation of study results, or, in the judgment of the investigator, make the investigator and/or sponsor unsuitable for enrollment.

Sites / Locations

  • The Third Xiangya Hospital of Central South University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QLM3003

QLM3003 Placebo

Arm Description

QLM3003 Single dose

QLM3003 vehicle Single dose

Outcomes

Primary Outcome Measures

Incidence (severity and causality) of any local and systemic adverse events
adverse events

Secondary Outcome Measures

Maximum Plasma Concentration (Cmax) of QLM3003
Cmax
Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003
AUC0-t
Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003
AUC0-∞

Full Information

First Posted
June 22, 2023
Last Updated
September 17, 2023
Sponsor
Qilu Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05932888
Brief Title
Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects
Official Title
A Single Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QLM3003 in Healthy Adult Chinese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2023 (Actual)
Primary Completion Date
August 5, 2023 (Actual)
Study Completion Date
August 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.
Detailed Description
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.Eligible subjects will be assigned to a sequential treatment cohort and randomized to each treatment group (active/placebo ). Subject enrollment will continue into the next cohort after review of the dose safety from the previous dose cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QLM3003
Arm Type
Experimental
Arm Description
QLM3003 Single dose
Arm Title
QLM3003 Placebo
Arm Type
Placebo Comparator
Arm Description
QLM3003 vehicle Single dose
Intervention Type
Drug
Intervention Name(s)
QLM3003
Intervention Description
1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)
Intervention Type
Drug
Intervention Name(s)
QLM3003 Placebo
Intervention Description
1%(10g∶0.1g)or 1.5%(10g∶0.15g)or 2%(10g∶0.2g)(matching corresponding study medication)
Primary Outcome Measure Information:
Title
Incidence (severity and causality) of any local and systemic adverse events
Description
adverse events
Time Frame
8 days
Secondary Outcome Measure Information:
Title
Maximum Plasma Concentration (Cmax) of QLM3003
Description
Cmax
Time Frame
8 days
Title
Area Under the Plasma Concentration-Time Curve From 0 to t of QLM3003
Description
AUC0-t
Time Frame
8 days
Title
Area Under the Plasma Concentration-Time Curve From 0 to infinity of QLM3003
Description
AUC0-∞
Time Frame
8 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adult subjects between 18-55 years of age (inclusive), male or female The body mass index (BMI equal to body mass/square of body height) of the subjects ranges from 19 to 26 kg/m2 (inclusive), and males of weight not less than or equal to 50 kg, females of weight not less than or equal to 45 kg. Subjects have no sperm donation, egg donation plan, no pregnancy plan and voluntarily take effective contraceptive measures from 14 days before signing the informed consent form to 30 days after the last dose of investigational product; The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form. Exclusion Criteria: Patients who are allergic to the investigational product or its preparation ingredients, or have previous allergic diseases, history of drug allergy, history of skin allergy, or known to be hypersensitive; Patients with clinically relevant skin diseases that are contraindicated in the study or affect the assessment of the administration site at screening, including but not limited to psoriasis, eczema, acne, atopic dermatitis, dysplastic mole, or other skin lesions, and a history of skin cancer; Skin conditions affecting the assessment of the study drug such as ulceration, injury, sunburn, redness and swelling, rash, or abnormal fever, tattoos, birthmarks, skin scars, skin perforations, skin infections on the skin of the target application area at screening and before administration, or disagreeing to removing the hair on the skin of this site; Pregnant or lactating women, and those who cannot use one or more non-drug contraceptive measures during the trial; Patients who have difficulty in collecting blood or cannot tolerate venipuncture, and have a history of fainting needle halo; Those who have special requirements for diet and cannot abide by the unified diet; Excessive consumption of tea, coffee or caffeinated beverages, or consumption of grapefruit, or xanthine-rich foods or beverages within 14 days before screening, or inability to stop consumption of xanthine-rich foods or beverages, or grapefruit or pomelo and products containing grapefruit or pomelo ingredients within 48 hours before dosing and during the trial; Patients who smoked more than 5 cigarettes or the same amount of tobacco daily for 3 months before screening and could not stop using any tobacco products during the trial; Regular drinkers within 6 months before screening, i.e., those who drank more than 14 units of alcohol per week or could not stop using any alcohol-containing products during the trial; or those who took any alcohol-containing products within 48 hours before the first dose, or those who tested positive for alcohol breath before randomization; Drug abusers or those who have used soft drugs within 3 months before screening or hard drugs within 1 year before screening or those who have positive drug abuse screening before randomization; Blood donation or massive blood loss, receiving blood transfusion or using blood products within 3 months before screening; Any surgical procedure within 30 days prior to Screening or planned during the study and within 30 days after the end of the study; Patients who have received any live vaccines within 30 days before screening or need to receive live vaccines during the study; Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days before screening; Patients who have taken any drug or health product within 14 days before screening; Patients who have participated in and used any drug or medical device clinical trials within 3 months before screening, or within 5 half-lives of other investigational drugs before screening; Patients with previous serious or clinically significant diseases or abnormalities at screening, including but not limited to cardiovascular system, nervous system, respiratory system, blood and lymphatic system, digestive system, immune system, liver, kidney, metabolism and bone system diseases or psychiatric diseases or history of malignant tumors; Abnormal vital signs or clinically significant abnormalities in physical examination, ECG and laboratory tests (subject to the judgment of the clinical study physician); Patients with active tuberculosis suggested by clinical symptoms, signs, laboratory tests or chest radiography at screening; Patients whose white blood cell count, neutrophil count, lymphocyte count or hemoglobin in blood routine examination exceed the normal reference range and have clinical significance judged by the investigator; May increase study-related risks, may interfere with interpretation of study results, or, in the judgment of the investigator, make the investigator and/or sponsor unsuitable for enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
guoping Yang, doctor
Organizational Affiliation
The Third Xiangya Hospital of Central South University
Official's Role
Study Director
Facility Information:
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China

12. IPD Sharing Statement

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Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects

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