BG-A3004
BiologicalAdministered subcutaneously
NCT Number: NCT07412691
This is the first-in-human study of BG-A3004. The study will evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and pharmacodynamics (PD) of BG-A3004 after single and multiple doses administered in different dose levels in healthy participants (Part A) and patients with immune-mediated skin diseases (Part B), respectively.
Study details include:
* The study duration will be approximately 3 years. * The treatment duration will be 1 dose for Part A and 4 doses for Part B. * Safety follow-up period is 168 days after the last dose
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1
Beijing Tongren Hospital, Cmu, Beijing, Beijing Municipality, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part A (SAD) specific Inclusion criteria
Part B (MAD) specific inclusion criteria:
Exclusion criteria
Part B(MAD) specific exclusion criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Administered subcutaneously
Administered subcutaneously
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant abnormalities from laboratory tests, vital signs and electrocardiogram results
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Time frame: up to 24 weeks for Part A and 36 weeks for Part B
Time frame: up to 36 weeks
Contact information is provided by the study sponsor or research team.
BeOne Medicines
Industry
A Phase 1, Randomized, Double-Blind, Placebo Controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of BG-A3004 in Healthy Participants and Patients With Immune-Mediated Skin Diseases
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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