A Phase 1 Clinical Study of BW-20805-2-1001 in Healthy Participants

ConditionHV

Trial statusNot yet recruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-60

SponsorShanghai Argo Biopharmaceutical Co., Ltd.

About this trial

A Phase 1 Clinical Study Of BW-20805-2-1001 in Healthy Participants

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Must have given written informed consent and be able to comply with all study requirements

Males or females aged 18 to 60 years old, inclusive, at the time of informed consent.

Body mass index (BMI) ≥18 and ≤32 kg/m2 and body weight ≥50 kg Female participants must be non-pregnant

Male participants with female partners of child-bearing potential must agree to use acceptable methods of contraception from screening until 48 weeks following administration of the study drug

Disqualifiers

Any clinically significant chronic medical condition or clinically significant abnormality in physical examination that

Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site

Hospitalization for any reason within 60 days prior to screening.

Presence of carcinoma and history of carcinoma

Trial design

Design model

Parallel

Treatments tested in this trial

BW-20805
Drug
Cohort 1 will receive SC administrations of BW-20805 on Day1.
BW-20805
Drug
Group 2 will receive SC administrations of BW-20805 on Day1
BW-20805-2
Drug
Group 3 will receive SC administrations of BW-20805-2 on Day1.

Treatment groups

24 Participants

are divided into 3 treatment groups

Group A: Cohort 1Experimental treatment 1 intervention

Group B: Cohort 2Experimental treatment 1 intervention

Group C: Cohort 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Primary Endpoints

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Time frame

week 48

Secondary outcomes

Secondary Endpoints

Maximum observed plasma concentration (Cmax), - Time to maximum plasma concentration (Tmax),

Time frame

week 48

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Argo Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: