NCT04271514已完成1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-dose Escalation, Multiple-dose Escalation, and Food Effect Study of RPT193 in Healthy Subjects and Patients With Moderate to Severe Atopic Dermatitis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 14
- 主要终点
- Incidence of Treatment Emergent Adverse Events
研究概览
简要总结
This study is a first-in-human, 3-part, multi-center, Phase 1, randomized, double-blind, placebo-controlled study with RPT193 in up to 64 healthy male and female subjects and 30 male and female patients with atopic dermatitis. RPT193 is an orally-available, potent, and selective antagonist of CCR4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parts A & B (COMPLETED ENROLLMENT):
- •Healthy male or female
- •18-55 years of age, inclusive
- •At least 50 kg in weight
- •BMI: 18.0-30.0 kg/m2, inclusive
- •Part C (COMPLETED ENROLLMENT):
- •Male or female with atopic dermatitis
- •18-65 years of age, inclusive
- •BMI between 18.0 (inclusive) and <40.0 kg/m2
- •Body surface area (BSA) with AD involvement ≥10%
- •Eczema Area and Severity Index (EASI) score ≥12
- •Validated Investigator's Global Assessment (vIGA) ≥3
- •History of inadequate response to treatment with topical medications, such as corticosteroids or calcineurin inhibitors, or patients for whom topical treatments are otherwise medically inadvisable
排除标准
- •Parts A & B (COMPLETED ENROLLMENT):
- •Use of tobacco products within 60 days prior to drug administration
- •History of alcohol abuse or drug addiction
- •Positive drug and alcohol screen
- •Participation in a drug study within 60 days prior to drug administration
- •Donation or loss of more than 100 mL of blood within 60 days prior to drug administration.
- •Donation or loss of more than 1.5 liters of blood (for male subjects) / more than 1.0 liters of blood (for female subjects) in the 10 months prior to drug administration.
- •Part C (COMPLETED ENROLLMENT):
- •Any serious and/or uncontrolled medical condition
- •History of alcohol abuse or drug addiction
- •Positive drug and alcohol screen
研究组 & 干预措施
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - active
Experimental
Increasing doses of RPT193 will be administered to healthy volunteers
干预措施: RPT193 (Drug)
COMPLETED ENROLLMENT -- Single Dose Escalation Part A - placebo
Placebo Comparator
Matching placebo will be administered to healthy volunteers
干预措施: Placebo (Drug)
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - active
Experimental
Increasing doses of RPT193 will be administered once/day for 7 days to healthy volunteers
干预措施: RPT193 (Drug)
COMPLETED ENROLLMENT -- Multiple Dose Escalation Part B - placebo
Placebo Comparator
Matching placebo will be administered once/day for 7 days to healthy volunteers
干预措施: Placebo (Drug)
COMPLETED ENROLLMENT -- Expansion Part C - active
Experimental
RPT193 will be administered daily for 28 days to patients with atopic dermatitis
干预措施: RPT193 (Drug)
COMPLETED ENROLLMENT -- Expansion Part C - placebo
Placebo Comparator
Matching placebo will be administered daily for 28 days to patients with atopic dermatitis
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of Treatment Emergent Adverse Events
时间窗: up to Day 16 (Part A: SAD); up to Day 22 (Part B: MAD); up to Day 43 (Part C)
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment
次要结局
未报告次要终点
研究者
研究点 (14)
Loading locations...
相似试验
终止
1 期
First in Human Study of AL-704; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis CChronic Hepatitits CNCT02510248Alios Biopharma Inc.42
已完成
1 期
Safety and Tolerability of PNT001 in Healthy AdultsHealthyNCT04096287Pinteon Therapeutics, Inc49
已完成
1 期
Phase 1 Multicenter, Single Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Response of PE0139 Injection in Adult Subjects With Type 2 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)NCT01835730PhaseBio Pharmaceuticals Inc.37
已完成
1 期
Safety, Tolerability, and Pharmacokinetics of Ascending Topical Doses of TCP-25 Applied to Epidermal Suction Blister Wounds, Non-Healing Leg Ulcers and Patients With Dystrophic Epidermolysis Bullosa.BlisterWound of SkinVaricose Ulcer of Lower LimbEpidermolysis BullosaNCT05378997Xinnate AB35
终止
1 期
A Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of Single and Multiple Ascending Doses of GDC-0334 and the Effect of Food on the Pharmacokinetics of GDC-0334 in Healthy Adult ParticipantsHealthy VolunteersNCT03381144Genentech, Inc.66
相关资讯
RPT193 Shows Clinical Improvement in Atopic Dermatitis Patients- RPT193, an oral CCR4 antagonist, demonstrated greater improvements in clinical efficacy endpoints compared to placebo in adults with moderate to severe atopic dermatitis.
- The Phase 1 study highlighted that RPT193 was well-tolerated, with most treatment-emergent adverse events being mild to moderate across all cohorts.
- Patients receiving RPT193 400 mg QD showed numerically greater improvements in EASI, BSA, vIGA, and SCORAD scores compared to the placebo group over 28 days.
- Post-hoc analysis revealed statistically significant differences in efficacy endpoints at day 43, suggesting sustained efficacy beyond the treatment period.2 years agoOral CCR4 Antagonist RPT193 Shows Promise in Atopic Dermatitis Phase 1 Trial- RPT193, an oral CCR4 antagonist, was well-tolerated in healthy subjects and those with moderate-to-severe atopic dermatitis in a Phase 1 trial.
- Atopic dermatitis patients treated with RPT193 monotherapy showed numerically greater improvements in clinical efficacy endpoints compared to placebo by day 29.
- Statistically significant improvements in clinical efficacy were observed two weeks post-treatment (Day 43) in RPT193-treated subjects versus placebo.
- Skin biopsies from RPT193-treated subjects showed significant changes in transcriptional profiles correlated with clinical improvements.3 years agoRapt Therapeutics' RPT193 Faces Setback in Atopic Dermatitis Development• RAPT Therapeutics' RPT193 saw its Phase Transition Success Rate (PTSR) for atopic dermatitis decrease by 13 points to 78%, despite positive Phase Ib trial results.
• The Phase Ib trial data showed a 36.3% improvement from baseline in Eczema Area and Severity Index (EASI) score with RPT193, compared to 17% with placebo over four weeks.
• RPT193's Likelihood of Approval (LoA) also experienced a slight decrease of one point, settling at 3%, based on GlobalData's analysis.
• Rapt Therapeutics is planning to advance RPT193 into a Phase IIb trial for atopic dermatitis, with the drug targeting CCR4 on Th2 cells.5 years ago