16 completed, 2 terminated, 2 unknown, 1 active not recruiting. 18 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 18 | Completed 14, Unknown 2, Active not recruiting 1, Terminated 1 |
| Phase 2 | 4 | Completed 2, Recruiting 1, Terminated 1 |
Follow Safety and Tolerability: new trials by email Literature Review of Safety and Tolerability trials Research Report on Safety and Tolerability
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Food Effect, Efficacy and Safety of MKP10241 in Healthy and Obese Adult Participants, With and Without Diabetes MKP10241, Placebo - Type 2 Diabetes Mellitus (T2DM), Food Effect | Phase 2 | Recruiting | Mankind Pharma Limited | 68 | 2025-08-12 | 2025-09-29 |
| SAD Evaluation of Safety, Tolerability, PK, and PD of MDI-2517 in Healthy Participants MDI-2517, Placebo - Safety and Tolerability | Phase 1 | Completed | MDI Therapeutics, Inc. | 48 | 2024-05-17 | 2025-03-14 |
| Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics/-Dynamics of AK1967 (Procizumab) AK1967 (Procizumab), Placebo - Safety and Tolerability, Healthy Volunteers | Phase 1 | Completed | 4TEEN4 Pharmaceuticals GmbH | 24 | 2024-03-07 | 2026-02-27 |
| A Study to Evaluate the Safety of Fenretinide in Healthy Volunteers Fenretinide, Placebo - Safety and Tolerability | Phase 1 | Completed | Island Pharmaceuticals | 25 | 2023-11-22 | 2025-01-27 |
| Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects DF-003, Placebo - Healthy, Safety and Tolerability | Phase 1 | Active not recruiting | Shanghai Yao Yuan Biotechnology Ltd. (also known as Drug Farm) | 96 | 2023-09-15 | 2026-06-03 |
| A Trial Assessing Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP7570 ZP7570, Placebo - Safety and Tolerability | Phase 1 | Terminated | Zealand Pharma | 84 | 2023-09-15 | 2025-04-25 |
| Phase 1 Clinical Study of JMKX003142 Tablets JMKX003142 will be administered orally, Placebo in Cohorts 1 to 7, Placebo in 3 Cohorts - Safety and Tolerability | Phase 1 | Unknown | Jemincare | 106 | 2023-07-06 | 2023-10-17 |
| Safety, Tolerability of JMKX003002 in Phase 1 Study in Healthy Subjects JMKX003002 will be administered orally, Placebo in Cohorts 1 to 5, Placebo in 2 Cohorts - Safety and Tolerability | Phase 1 | Unknown | Jemincare | 80 | 2023-05-09 | 2023-06-18 |
| Single-Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of YJ001 in Healthy Volunteers YJ001 for Spray Use, Placebo of YJ001 for Spray Use - Safety and Tolerability | Phase 1 | Completed | Yuejia Pharmaceuticals (USA), Inc. | 32 | 2022-08-15 | 2023-01-04 |
| Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants Experimental drug: ESK-001, Placebo - Safety and Tolerability | Phase 1 | Completed | Alumis Inc | 49 | 2022-05-12 | 2023-05-09 |
| A Phase I Pharmacokinetics Study for KT07 Capsule Low dose KT07, High dose KT07, Low dose Placebo - Healthy Adult Subjects, Pharmacokinetics | Phase 1 | Completed | Yiling Pharmaceutical Inc. | 26 | 2022-01-07 | 2022-10-17 |
| Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin Sevuparin - Safety and Tolerability | Phase 1 | Completed | Modus Therapeutics AB | 24 | 2019-02-06 | 2019-07-16 |
| A First in Human Study to Evaluate the Safety, Tolerability and PK of GB1211 in Healthy Subjects GB1211, Placebo - Safety and Tolerability | Phase 1 | Completed | Galecto Biotech AB | 78 | 2019-01-14 | 2021-03-17 |
| Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers GT-002, Placebo oral capsule - Safety and Tolerability | Phase 1 | Completed | Gabather AB | 32 | 2018-12-17 | 2020-02-05 |
| HEPLISAV-B Hepatitis B Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's-Tyrosine Kinase Inhibitor (BTK-I) HEPLISAV-B - Hepatitis, Safety and Tolerability | Phase 2 | Completed | National Heart, Lung, and Blood Institute (NHLBI) | 78 | 2018-12-07 | 2022-02-08 |
| Response to the SHINGRIX Varicella Zoster Virus (VZV) Vaccine in Chronic Lymphocytic Leukemia (CLL) and CLL Treated With Bruton's Tyrosine Kinase Inhibitor (BTK-I) Zoster Vaccine Recombinant, Adjuvanted - Safety and Tolerability, Compare SHINGRIX Vaccine Response Rates | Phase 2 | Completed | National Heart, Lung, and Blood Institute (NHLBI) | 116 | 2018-12-07 | 2023-08-04 |
| PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD inhaled human insulin, Insulin Lispro (Humalog U-100) - Safety and Tolerability | Phase 2 | Terminated | Dance Biopharm Inc. | 40 | 2018-02-06 | 2019-09-13 |
| DP13 SAD & MAD in Healthy Male Subjects DP13, placebo - Safety and Tolerability | Phase 1 | Completed | Damian Pharma AG | 48 | 2017-03-06 | 2018-04-17 |
| Study Comparing the Pharmacokinetics, Pharmacodynamics, and Safety of K-312 in Healthy Adult Volunteers K-312, Placebo - Safety and Tolerability | Phase 1 | Completed | Kowa Research Institute, Inc. | 2013-05-01 | 2013-12-31 | |
| Pharmacokinetic Profile in Plasma and Epithelial Lining Fluid of Finafloxacin Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days - Safety and Tolerability | Phase 1 | Completed | MerLion Pharmaceuticals GmbH | 18 | 2012-01-01 | 2017-02-20 |
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Obesity (2) · Asthma (1) · Breast Neoplasms (1) · Diabetes Mellitus, Type 2 (1) · Endometrial Neoplasms (1) · Hepatitis (1) · Hereditary Sensory and Autonomic Neuropathies (1) · Herpes Simplex (1) · Herpes Zoster (1) · Leukemia, Lymphocytic, Chronic, B-Cell (1) · Liver Cirrhosis (1) · Non-alcoholic Fatty Liver Disease (1) · Ovarian Neoplasms (1) · Overweight (1) · Pulmonary Disease, Chronic Obstructive (1)
Pathological Conditions, Signs and Symptoms (5) · Pathologic Processes (3) · Body Weight (2) · Chronic Disease (2) · Digestive System Diseases (2) · Disease Attributes (2) · Endocrine System Diseases (2) · Immune System Diseases (2) · Liver Diseases (2) · Neoplasms (2) · Nutrition Disorders (2) · Nutritional and Metabolic Diseases (2) · Overnutrition (2) · Signs and Symptoms (2) · Skin Diseases (2)
Fenretinide (1) · Heplisav-B (1) · Hypromellose Derivatives (1) · Insulin Lispro (1) · Tablets (1) · capivasertib (1) · finafloxacin (1) · ponesimod (1) · procizumab (1) · sevuparin (1)
Jemincare (2) · National Heart, Lung, and Blood Institute (NHLBI) (2) · 4TEEN4 Pharmaceuticals GmbH (1) · Actelion (1) · Alumis Inc (1) · AstraZeneca (1) · Damian Pharma AG (1) · Dance Biopharm Inc. (1) · Gabather AB (1) · Galecto Biotech AB (1) · Island Pharmaceuticals (1) · Kowa Research Institute, Inc. (1) · MDI Therapeutics, Inc. (1) · Mankind Pharma Limited (1) · MerLion Pharmaceuticals GmbH (1)
United States (12) · United Kingdom (4) · Australia (2) · China (2) · Netherlands (2) · Canada (1) · Denmark (1) · Finland (1) · France (1) · Germany (1) · Italy (1) · Japan (1) · Singapore (1) · Spain (1)
Christopher MT Pleyer, M.D. (2) · Ashley Brooks, MBChB (1) · Christopher Argent, MD (1) · Darren Wilbraham, MBBS, DCPSA (1) · David Wyatt, MD (1) · Dr Ashley Brooks, MBChB (1) · Dr Bertil Lindmark MD PHD, Chief Medical Officer (1) · Gaia Schiavon, MSD (1) · Javid Ghandehari, MD (1) · Jing Zhang (1) · Mark Bradley (1) · Mark H. Gottfried, MD (1) · Nan Zhang, PhD (1) · Stephen Hall, MBBS, FRACP (1) · Timothy S Bailey, MD (1)
PMID 33259596, PMID 29066505, PMID 32312891, PMID 33863913, PMID 34250397, PMID 35157769, PMID 36914591, PMID 36914828, PMID 42166148
2018 (1)