Age-related Macular DegenerationPhase 1NCT04894071
QA102 Phase 1 Study in Healthy Young and Older Adult Subjects
A Phase 1 study testing QA102 in people with Age-related Macular Degeneration, run by Smilebiotek Zhuhai Limited at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- QA102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 15 Nov 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit Inc.
Madison, Wisconsin, 53704
About this study
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
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.
- Conditions
- Age-related Macular Degeneration
- Being tested
- QA102, Placebo
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QA102Drug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| QA102 group | Experimental | Not described Receives: Drug: QA102 |
| Placebo group | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days after dosing
Secondary outcomes (3)
Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12]
Measured: up to 12 hours postdose
Maximum observed plasma concentration [Cmax]
Measured: Up to 48 hours postdose
time of the maximum observed plasma concentration [tmax]
Measured: up to 48 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start17 May 2021
- Primary completion15 Nov 2021
- Study completion15 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smilebiotek Zhuhai Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894071
- Sponsor's protocol ID
- QA102-CS101
- Status last verified
- Dec 2021
- First submitted
- 6 May 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04894071
- Acronym / sponsor ID
- QA102-CS101
- Conditions
- Age-related Macular Degeneration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Smilebiotek Zhuhai LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 15 Nov 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QA102 group | Experimental | Drug: QA102 |
| Placebo group | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QA102Intervention 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. | Drug | QA102 group |
| PlaceboIntervention 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. | Drug | Placebo group |
Primary outcome
Incidence and severity of Adverse Events
Time frame: Up to 7 days after dosing
To evaluate the safety and tolerability of single and multiple ascending oral doses of QA102 in healthy young adult and elderly subjects.
3 secondary outcomes
Area under the plasma concentration-time curve (AUC) from time zero to 12 hours postdose [AUC0-12]
Time frame: up to 12 hours postdose
Maximum observed plasma concentration [Cmax]
Time frame: Up to 48 hours postdose
time of the maximum observed plasma concentration [tmax]
Time frame: up to 48 hours postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QA102 in people with Age-related Macular Degeneration, run by Smilebiotek Zhuhai Limited at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Adverse Events (time frame: Up to 7 days after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.