This is a phase 1/1b randomized, double blind, placebo-controlled, single dose escalation (SAD) and multiple dose escalation (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ZL-1503 in healthy volunteers and participants with moderate to severe atopic dermatitis (AD)
The study consists of two parts: * Part A: single ascending dose in healthy volunteers * Part B: multiple ascending doses in adult participants with moderate to severe AD
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
Veracity Clinical Research
Woolloongabba, Queensland, Australia
RECRUITINGSkin Health Institute
Carlton, Victoria, Australia
RECRUITINGNumber of participants with adverse events (AEs)
Time frame: Up to 48 weeks after last intervention
Number of participants with serious adverse events (SAEs)
Time frame: Up to 48 weeks after last intervention
Number of participants with clinical laboratory abnormalities
Time frame: Up to 48 weeks after last intervention
Number of participants with vital sign abnormalities
Time frame: Up to 48 weeks after last intervention
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 48 weeks after last intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participants with moderate to severe atopic dermatitis will receive placebo.
Peking University Third Hospital
Beijing, Beijing Municipality, China
RECRUITINGShandong Provincial Dermatology Hospital
Jinan, Shandong, China
RECRUITINGShanghai Skin Disease Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGHangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGAotearoa Clinical Trials
Auckland, Auckland, New Zealand
RECRUITINGMomentum Auckland
Takapuna, Auckland, New Zealand
RECRUITINGMomentum Hamilton
Hamilton, Hamilton, New Zealand
RECRUITINGMomentum Palmerston North
Palmerston North, Mananwatu, New Zealand
RECRUITING...and 2 more locations