QA102 Phase 1 Study in Healthy Young and Older Adult Subjects

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

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.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Drug: QA102; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Covance Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Body mass index between 18.0 and 32.0 kg/m2, inclusive.
2. 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.
3. Females of nonchildbearing potential defined as permanently sterile or postmenopausal. Males will agree to use contraception.
4. Able to comprehend and willing to sign an ICF and to abide by the study restrictions.
5. 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:

1. 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.
2. 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).
3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the investigator (or designee).
4. 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.
5. 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.
6. Female subjects (surgically sterile females only) with a positive pregnancy test at screening or check in or who are lactating.
7. History of alcoholism or drug/chemical abuse within 2 years prior to check in.
8. Positive urine drug or alcohol results at screening or check in.
9. 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.
10. Consumption of alcohol from 48 hours prior to check-in.
11. Administration of any vaccine, including a Coronavirus Disease 2019 vaccine, within the past 30 days prior to dosing.
12. Subjects who, in the opinion of the investigator (or designee), should not participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo group	Drug: Placebo; 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.
Experimental: QA102 group	Drug: QA102; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 7 days after dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12]	up to 12 hours postdose
Maximum observed plasma concentration [Cmax]	Up to 48 hours postdose
time of the maximum observed plasma concentration [tmax]	up to 48 hours postdose

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal clearance (CLR )		up to 24 hours postdose
Metabolite characterization of QA102	To characterize metabolites of QA102 in plasma samples after multiple oral doses of QA102 in healthy adult subjects.	Within 24 hours after last dose

Collaborators and Investigators

• Sponsor: Smilebiotek Zhuhai Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 15, 2021

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: December 31, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: QA102-CS101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No