A First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Hemay007
Overview
- Phase
- Phase 1
- Intervention
- Hemay007
- Conditions
- Inflammatory Bowel Disease
- Sponsor
- Hemay Pharmaceutical PTY. LTD.
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
- Last Updated
- 8 years ago
Overview
Brief Summary
This phase I study designed in 3 parts is a randomized, placebo-controlled, sequential ascending-dose study of healthy volunteers. The safety, tolerability and pharmacokinetics of ascending single and multiple dose of Hemay007 will be assessed in Part 1 and Part 3, respectively. Food effect following a single oral dose will be evaluated in Part 2.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female aged between 18 and 45 years (inclusive).
- •Body weight \>45 kg for females and \> 50 kg for males, and Body Mass Index (BMI) between 19 and 30 kg/m2 inclusive.
- •Female participants who return a negative pregnancy test (serum or urine) at both the screening visit and at Day -
- •Female participants of childbearing potential with male partners must use a highly effective method of contraception/birth control (methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly) and if currently lactating, participant's should not breast feed an infant while on this study, and for 3 months after the last dose of study drug has been taken.
- •Examples of acceptable forms of highly effective contraception include:
- •Established use of oral, injected or implanted hormonal methods of contraception.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- •True abstinence: When this is in line with the participant's preferred and usual lifestyle.
- •Examples of non-acceptable methods of contraception include:
Exclusion Criteria
- Not provided
Arms & Interventions
Hemay007
Part 1: Single ascending dose Group Hemay007 tablets will be taken orally once daily in doses of 0.2g, 0.6g,1.2g, 2g, 3g. Part 2: Food effect group Hemay007 tablets will be taken orally in single dose with a high-fat, high-calorie meal or at overnight fasting. Part 3: Multiple doses group Hemay007 tablets will be taken orally once daily in low, medium, high doses
Intervention: Hemay007
Placebo
Part 1: Single ascending dose Group Placebo tablets will be taken orally once daily in doses of 0.2g, 0.6g,1.2g, 2g, 3g. Part 3: Multiple doses group Placebo tablets will be taken orally once daily in low, medium, high doses
Intervention: placebo
Outcomes
Primary Outcomes
Adverse events assessments after single and multiple ascending dose administration at baseline and repeatedly until study completion
Time Frame: Starting about 24 hours before dosing and continued until about 7-14 days after last dose
This safety outcome combines the measure of the number of subjects experiencing adverse events (AEs), the nature and severity of those AEs and their relationship to the study treatments.
Secondary Outcomes
- PK of Hemay007: Observed maximum concentration (Cmax) in Part 1 and Part 2(Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h)
- PK of Hemay007: Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) in Part 1 and Part 2(Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h)
- PK of Hemay007: time to reach the maximum concentration (Tmax) in Part 3(Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h)
- PK of Hemay007: Observed maximum concentration (Cmax) in Part 3(Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h)
- PK of Hemay007: Trough Plasma Concentrations in Part 3(Day 7 and 14 pre-dose)
- PK of Hemay007: Area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast) after the first dose administration in Part 3(Day 1 and 21: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2 and 22: 24h and 36h, Day 3 and 23: 48h and 60h, Day 4 and 24: 72h)
- Pharmacokinetics (PK) of Hemay007: time to reach the maximum concentration (Tmax) in Part 1 and Part 2(Day 1: pre-dose; 0.25h; 0,5h; 1h; 2h; 3h; 4h; 6h; 8h; 12h post dose, Day 2: 24h and 36h, Day 3: 48h and 60h, Day 4: 72h)