Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants (NCT05112159) | Clinical Trial Compass
CompletedPhase 1
Phase 1 Study of IPG1094 Safety, Tolerability, and PK in Healthy Participants
Australia76 participantsStarted 2021-09-27
Plain-language summary
This is a phase 1, first-in-human, randomized, double-blind, placebo-controlled, single dose escalation study to evaluate the safety, tolerability, and PK of single dose orally administered IPG1094 in healthy adult participants.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. Healthy adult male or female participants between 18 and 50 years of age (inclusive).
✓. Body weight between 50 and 100 kg (inclusive) and body mass index (BMI) within 18\~32 kg/m2 (inclusive).
✓. In good health as determined by screening tests. Good health is defined as having no clinically relevant abnormalities identified by a detailed medical history, full physical examination (including measurement of blood pressure and pulse rate), 12-lead ECG, and clinical laboratory tests.
✓. A negative result on urine drug screen and a repeat negative result on Day -1 (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
✓. Female participants must not be pregnant or breastfeeding and must use an effective contraception method (as described in Section 4.5.4), with the exception of participants who have undergone sterilization in the preceding 3 months, or who are postmenopausal.
✓. Provide written informed consent prior to undertaking any study-related procedures.
✓. Must not be under any administrative or legal supervision or under institutionalization as per a regulatory or juridical order.
Exclusion criteria
✕. Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, musculoskeletal, rheumatological, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
✕. Frequent severe headaches and/or migraines, recurrent nausea and/or vomiting (defined as vomiting more than twice a month).
What they're measuring
1
Adverse Events
Timeframe: Part A (SAD)：From signed ICF up to D8；Part B (MAD)：From signed ICF up to D17；Part C (MAD)：From signed ICF up to D17；Part D (FE)：From signed ICF up to D12；
✕. Made a blood donation of any volume within 2 months prior to the first dose.
✕. Symptomatic postural hypotension, irrespective of actual decrease in blood pressure, or asymptomatic postural hypotension with a decrease in systolic blood pressure ≥30 mmHg within 3 minutes of moving from supine to standing position.
✕. Presence or history of drug hypersensitivity, or anaphylactic reaction, diagnosed and treated by a physician.
✕. Known hypersensitivity to any component of the IMP formulation.
✕. History or presence of drug or alcohol abuse (defined as alcohol consumption more than 2 units per day on a regular basis).
✕. Regular smoking (defined as more than 5 cigarettes or equivalent per week), or unable to stop smoking during the study. Occasional smokers may be enrolled.