SAD/MAD Study in Healthy Subjects and Adults With UC to Evaluate Safety, Tolerability, PK, PD of AMT-101
- Registration Number
- NCT04224857
- Lead Sponsor
- Applied Molecular Transport
- Brief Summary
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
- Detailed Description
A randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active UC who have had an inadequate response to or demonstrated intolerance to 5-ASA.
Subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. In case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance.
Patients may be
1. naïve to anti-TNFα therapy or
2. have failed or demonstrated intolerance to anti-TNF-α therapy.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
PART A (Healthy Volunteers)
- Male subject in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening
- Between 18 and 45 years of age, inclusive.
- Body Mass Index (BMI) between 18 and 30 kg/m2 (inclusive).
PART B (Adult Ulcerative Colitis)
- Male and Female patients 18 years and older
- Documented diagnosis of UC for at least 3 months duration
- Stable mild to moderate UC, as defined by the following criteria: Total Mayo score (excluding PGA) at least 3 but not greater than 7:
- Patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine)
PART A and PART B
- Known hypersensitivity or allergy to AMT-101 or excipient contained in the drug formulation.
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
PART B
- Clinical findings of Crohn's disease
- A prior history of surgery for UC
- Prior use of integrin antagonists (vedolizumab, natalizumab), JAK kinase inhibitors (tofacitinib), cyclosporin or tacrolimus
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebos Placebo AMT-101 AMT-101 AMT-101
- Primary Outcome Measures
Name Time Method Incidence of Treatment-emergent adverse events (safety and tolerability) 14 days Single and multiple ascending doses of AMT-101 in healthy adult volunteers and patients with active UC by evaluation of incidence of treatment-related adverse events as assessed by CTCAE v4.03 and Modified Mayo Score criteria.
- Secondary Outcome Measures
Name Time Method Maximum plasma concentration (CMax) 14 days To assess the pharmacokinetics of AMT-101 and Total IL-10 in healthy volunteers and subjects with UC.
Pharmacodynamics 14 days To assess plasma IL-1Ra concentration in healthy volunteers and subjects with UC.
Trial Locations
- Locations (4)
LLC ARENSIA Exploratory Medicine
🇬🇪Tbilisi, Georgia
Medical Center of Harmoniya krasy, Department of clinical trials
🇺🇦Kyiv, Ukraine
Charité Research Organisation GmbH
🇩🇪Berlin, Germany
ICS ARENSIA Exploratory Medicine SRL
🇲🇩Chisinau, Moldova, Republic of