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QA102 Phase 1 Study in Healthy Young and Older Adult Subjects

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

QA102

Placebo

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Body mass index between 18.0 and 32.0 kg/m2, inclusive.
In good health, determined by no clinically significant findings from medical history, physical examination, visual acuity testing, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check in as assessed by the investigator or designee.
Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
Young (between 18 and 59 years of age, for Part 1 and 2) or Older (between 60 and 75 years of age, for Part 3) males or females of nonchildbearing potential, of any race, inclusive, at screening.

Exclusion Criteria:

Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections. Viral infections with symptoms resolved will be allowed up to 14 days prior to check-in.
History of malignancy of any type, other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years before check-in.
Female subjects (surgically sterile females only) with a positive pregnancy test at screening or check in or who are lactating.
History of alcoholism or drug/chemical abuse within 2 years prior to check in.
Positive urine drug or alcohol results at screening or check in.
Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (whichever is longer) prior to dosing.
Consumption of alcohol from 48 hours prior to check-in.
Administration of any vaccine, including a Coronavirus Disease 2019 vaccine, within the past 30 days prior to dosing.
Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Sites / Locations

Covance Clinical Research Unit Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

QA102 group

Placebo group

Arm Description

Outcomes

Primary Outcome Measures

Incidence and severity of Adverse Events

To evaluate the safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young adult and elderly subjects.

Secondary Outcome Measures

Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12]

Maximum observed plasma concentration [Cmax]

time of the maximum observed plasma concentration [tmax]

Full Information

NCT ID

NCT04894071

First Posted

May 6, 2021

Last Updated

December 31, 2021

Sponsor

Smilebiotek Zhuhai Limited

1. Study Identification

Unique Protocol Identification Number

NCT04894071

Brief Title

QA102 Phase 1 Study in Healthy Young and Older Adult Subjects

Official Title

A Phase 1, Randomized, Double-Masked, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral QA102 in Healthy Young and Older Adult Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

May 17, 2021 (Actual)

Primary Completion Date

November 15, 2021 (Actual)

Study Completion Date

November 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Smilebiotek Zhuhai Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This will be a double masked, randomized, placebo controlled, single and multiple oral dose study conducted in 3 parts. The safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young and older adult subjects will be evaluated. The study will also characterize the pharmacokinetic (PK) profile of QA102 in plasma and urine after single and multiple oral doses of QA102. Besides, the metabolite profile of QA102 will also be characterized. Part 1 will comprise a single dose, sequential cohort design. Part 2 will comprise a multiple dose, sequential cohort study. Part 3 will comprise a multiple dose, single cohort study in older subjects.

6. Conditions and Keywords

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

Age-related Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

QA102 group

Arm Type

Experimental

Arm Title

Placebo group

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

QA102

Intervention Description

Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of QA102 capsules), oral administration, single dose. Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration. Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of Placebo capsules), oral administration, single dose. Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration. Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration.

Primary Outcome Measure Information:

Title

Incidence and severity of Adverse Events

Description

To evaluate the safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young adult and elderly subjects.

Time Frame

Up to 7 days after dosing

Secondary Outcome Measure Information:

Title

Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12]

Time Frame

up to 12 hours postdose

Title

Maximum observed plasma concentration [Cmax]

Time Frame

Up to 48 hours postdose

Title

time of the maximum observed plasma concentration [tmax]

Time Frame

up to 48 hours postdose

Other Pre-specified Outcome Measures:

Title

renal clearance (CLR )

Time Frame

up to 24 hours postdose

Title

Metabolite characterization of QA102

Description

To characterize metabolites of QA102 in plasma samples after multiple oral doses of QA102 in healthy adult subjects.

Time Frame

Within 24 hours after last dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Body mass index between 18.0 and 32.0 kg/m2, inclusive. In good health, determined by no clinically significant findings from medical history, physical examination, visual acuity testing, 12 lead ECG, vital signs measurements, and clinical laboratory evaluations at screening and check in as assessed by the investigator or designee. Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception. Able to comprehend and willing to sign an ICF and to abide by the study restrictions. Young (between 18 and 59 years of age, for Part 1 and 2) or Older (between 60 and 75 years of age, for Part 3) males or females of nonchildbearing potential, of any race, inclusive, at screening. Exclusion Criteria: Subject is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study. Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee). History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee). Active or recent (within 30 days of screening) infection or history of recurrent chronic infections with underlying condition that may predispose one to infections. Viral infections with symptoms resolved will be allowed up to 14 days prior to check-in. History of malignancy of any type, other than surgically excised non-melanomatous skin cancers or in situ cervical cancer within 5 years before check-in. Female subjects (surgically sterile females only) with a positive pregnancy test at screening or check in or who are lactating. History of alcoholism or drug/chemical abuse within 2 years prior to check in. Positive urine drug or alcohol results at screening or check in. Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 30 days or 5 half-lives (whichever is longer) prior to dosing. Consumption of alcohol from 48 hours prior to check-in. Administration of any vaccine, including a Coronavirus Disease 2019 vaccine, within the past 30 days prior to dosing. Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Facility Information:

Facility Name

Covance Clinical Research Unit Inc.

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53704

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

QA102 Phase 1 Study in Healthy Young and Older Adult Subjects

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