A Phase I Study of QLS12010 Capsules: Safety, Tolerability, PK, PD, and Food Effects in Healthy Adults and Moderate to Severe Atopic Dermatitis Patients
Recruiting
Phase 1
Interventional Study
Atopic Dermatitis
Hidradenitis Suppurativa (HS)
Rheumatoid Arthritis (RA)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 102 (estimated)
- Sponsor
- Shanghai Qilu Pharmaceutical Research and Development Center LTD · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The goal of this clinical trial is to evaluate the safety, tolerability, PK, and PD of single and multiple ascending doses of QLS12010 Capsules and the effect of food on their PK profiles in healthy adult participants and participants with atopic dermatitis. This study consists of four parts: Part A is a single ascending dose (SAD) study, once sufficient safety and PK data are obtained from the SA…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria for Parts A-C:
* Males and females aged 18-45 (inclusive),
* Weight: ≥ 50 kg for males and ≥ 45 kg for females, body mass index (BMI): 18.0-30.0 kg/m2 (inclusive),
Inclusion Criteria for Part D:
* Female or male participants between the ages of 18 to 75 years of age.
* Chronic …
Contacts