Health TrialsbyHealthPanel

A Study to Evaluate the Safety, Tolerability, PK/PD of HEC-007 Injection in Healthy and Overweight/Obese Subjects

ConditionHealthy Subjects
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSunshine Lake Pharma Co., Ltd.

About this trial

This trial adopts a single-center, randomized, double-blind, placebo-controlled, dose-escalation design to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HEC-007 Injection after single-dose administration in healthy subjects and multiple-dose administration in overweight or obese subjects.

The trial consists of two parts: Part A is a single ascending dose (SAD) study, planning to enroll 54 Chinese healthy subjects; Part B is a multiple ascending dose (MAD) study, planning to enroll 72 Chinese overweight or obese subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Subjects understand and comply with the study procedures, voluntarily participate, and sign the informed consent form.

Healthy adult subjects (including borderline values) aged 18 to 45 years, regardless of sex.

Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. BMI =Body weight (kg)/height2 (m2), with a body mass index ranging from 19.0 to 35.0 kg/m2 (including boundary values).

Normal results or abnormalities deemed clinically insignificant by the investigator in vital signs, physical examination, laboratory tests, electrocardiogram, chest CT, abdominal ultrasound (liver, gallbladder, spleen, pancreas, and both kidneys), and thyroid ultrasound.

Disqualifiers

Those diagnosed with type 1, type 2, or other types of diabetes before screening;

History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia syndrome type 2 (MEN2) during screening, or genetic predisposition to MTC;

Acute, chronic, or suspected pancreatitis during screening, or prior pancreatectomy;

Those diagnosed with any malignancy within 5 years before screening (except for basal cell carcinoma treated curatively and considered cured);

Trial design

Design model

Parallel

Treatments tested in this trial

  • HEC-007 injection

    Drug

    Single dose escalation of HEC-007 injection in healthy subjects

  • Placebo

    Drug

    Single dose of placebo in healthy adults

  • HEC-007 injection

    Drug

    Multiple dose escalation of HEC-007 injection in Overweight or Obese Subjects

  • Placebo

    Drug

    Multiple dose of placebo in Overweight or Obese Subjects

Treatment groups

126 Participants
are divided into 4 treatment groups
Group A: SAD Stage: HEC-007 InjectionExperimental treatment 1 intervention
Group B: SAD Stage: PlaceboPlacebo comparator 1 intervention
Group C: MAD Stage: HEC-007 injectionExperimental treatment 1 intervention
Group D: MAD Stage: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Adverse events (AEs)

Time frame
Screening period up to day 43/day 113
2

The maximum plasma concentration (Cmax)

Time frame
Post-dose at day 1 to day 43/day 113
3

Time to maximum plasma concentration (Tmax)

Time frame
Post-dose at day 1 to day 43/day 113
4

Terminal half-life (t1/2)

Time frame
Post-dose at day 1 to day 43/day 113

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Sunshine Lake Pharma Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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