A Study to Evaluate MWN109 Injection in Healthy Subjects
ConditionOverweight or Obese
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Minwei Biotechnology Co., Ltd
About this trial
This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.
[Part A: SAD] BMI of 19.0 to 40.0 kg/m2 (inclusive). [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kg for males.
History of stable body weight for 3 months (defined as change < 5%).
Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
Disqualifiers
Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric, disorders as determined by the investigator (or designee).
History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
History of insulinoma or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with ≥ 3 times of hypoglycemia symptoms within 3 months prior to Screening.
History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
Trial design
Design model
Sequential
Treatments tested in this trial
Placebo
DrugSub cutaneous injection on the abdomen by a qualified member of study staff.
Subcutaneous single and mutiple dose
DrugSub cutaneous injection on the abdomen by a qualified member of study staff.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: placeboPlacebo comparator 2 interventions
Group B: MWN109 injectionActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration
Time frame
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration2
Number of participants with change in laboratory parameters following treatment administration
Changes in clinical laboratory parameters include urine drug screening, alcohol breath test. serum virology, pregnancy test. hematology, blood chemistry, urinalysis, coagulation function, and thyroid function.
Time frame
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration3
Number of participants with change in Vital signs following treatment administration
Vital signs include measurement of heart rate (HR) respiration rate (RR), systolic and diastolic blood pressure (BP) and body temperature.
Time frame
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration4
Incidence of anti-drug antibody (ADA) formation following treatment administration
Time frame
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administrationSecondary outcomes
1
PK parameters- Cmax: maximum observed concentration
Time frame
SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.2
PK parameters- -Tmax: time to reach maximum concentration
Time frame
SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.3
PK parameters- t½: half-life
Time frame
SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.4
PK parameters- AUC0-inf: area under the concentration-time curve from time zero to the theoretical infinite time
Time frame
SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.Sponsors and contacts
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Source ClinicalTrials.gov