Clinical trials: Tolerability
Herpes Simplex Virus
Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Doses of IM-250 in Healthy Volunteers
This is a first-in-human, phase I, open-label, monocenter, single dose-escalation study with 4 cohorts. The total trial duration for each participant will be not more than 98 d from screening to the end of the follow-up.
- Trial name
- NCT06435507
- Testing
- IM-250 (50 mg), IM-250 (100 mg), IM-250 (200 mg)
- Where
- Germany
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Innovative Molecules GmbH
Growth Hormone Deficiency (GHD)
Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
A six month study of ACP-001, a long-acting growth hormone product, versus standard human growth hormone therapy. ACP-001 will be given once-a-week, standard human growth hormone (hGH) will be given on a daily basis.
- Trial name
- NCT01947907
- Testing
- ACP-001, Human Growth Hormone
- Where
- 36 sites in Belarus, Bulgaria and 12 more
- Volunteers
- 53 people
- Sponsor
- Ascendis Pharma A/S
Chronic Obstructive Pulmonary Disease
AZD9668 Relative Bioavailability
This clinical study will aid future formulation development and optimisation of AZD9668 tablets by evaluating possible effects of minor changes to the formulation and process on the rate and extent of absorption.
- Trial name
- NCT01035411
- Testing
- AZD9668
- Where
- Germany
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Chronic Obstructive Pulmonary Disease (COPD)
A First Time in Man Study to Asses the Safety and Tolerability of AZD7624 in Healthy Subjects
This is a First in Human study to assess the safety and tolerability of AZD7624, following inhaled administration of single ascending doses in healthy male volunteers and female volunteers of non-child bearing potential.
- Trial name
- NCT01754844
- Testing
- AZD7624
- Where
- United Kingdom
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Hereditary Hemorrhagic Telangiectasia (HHT)
Phase 1b Study of TX002100 in Participants With Hematologic Support-Dependent Hereditary Hemorrhagic Telangiectasia (HHT)
The primary purpose of this study is to assess the safety and tolerability of TX002100 in participants with hereditary hemorrhagic telangiectasia (HHT).
- Trial name
- NCT07863609
- Testing
- TX002100
- Volunteers
- 20 people
- Sponsor
- Tectonic Operating Company, Inc.
Acute Myeloid Leukemia
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute myeloid leukemia.
- Trial name
- NCT03671564
- Testing
- Milademetan
- Where
- 8 sites in Japan
- Volunteers
- 14 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
HIV Infections
A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants
An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed…
- Trial name
- SPAN (NCT05291520)
- Testing
- VH3810109, rHuPH20
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Prurigo Nodularis, Pruritus
Efficacy of Abrocitinib for Reducing Pruritus in Adults With Prurigo Nodularis and Chronic Pruritus of Unknown Origin
The primary objective is to assess the efficacy, safety, and tolerability of Abrocitinib for the treatment of Prurigo Nodularis (PN) or Chronic Pruritus of Unknown Origin (CPUO) in patients experiencing moderate to severe…
- Conditions
- Prurigo Nodularis, Pruritus, Chronic Pruritus, Chronic Prurigo
- Trial name
- NCT05038982
- Testing
- Abrocitinib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Johns Hopkins University
Breast Cancer
Study Of SU011248 In Combination With Docetaxel And Trastuzumab In Patients With Advanced Breast Cancer HER-2 Positive
This is an exploratory trial evaluating the tolerability and preliminary anti-tumor activity of SU011248 combined with docetaxel and trastuzumab in patients with locally recurrent or metastatic breast cancer over-expressing…
- Trial name
- NCT00372424
- Testing
- Herceptin, Sunitinib, Taxotere
- Where
- 7 sites in Belgium, Italy
- Volunteers
- 26 people
- Sponsor
- Pfizer
Malaria, Falciparum
Amodiaquine Plus Artesunate Versus Lapdap Plus Artesunate in the Treatment of Uncomplicated P. Falciparum Malaria in Malawi
Sulfadoxine-pyrimethamine is the current first-line therapy for uncomplicated malaria in Malawi. Significant resistance of the P.
- Trial name
- NCT00164359
- Testing
- Amodiaquine plus artesunate, chlorproguanil-dapsone plus artesunate
- Where
- 3 sites in Malawi
- Volunteers
- 212 people
- Sponsor
- Centers for Disease Control and Prevention
Advanced Solid Tumor
A Study of BR101 Injection Alone in Subjects With Advanced Solid Tumors
This study is a phase Ia study of single drug BR101 for Advanced solid tumor. The main purpose of this study is to Evaluate the safety and tolerability of BR101monotherapy (single dose and multiple doses) in Subjects with…
- Trial name
- NCT06001580
- Testing
- BR101
- Where
- China
- Volunteers
- 15 people
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Gastric Cancer
Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2-expressing Gastric Cancer (DESTINY-Gastric03)
DESTINY-Gastric03 will investigate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of trastuzumab deruxtecan (T-DXd) alone or in combination with chemotherapy and/or immunotherapy in…
- Trial name
- DG-03 (NCT04379596)
- Testing
- Fluorouracil (5-FU), Capecitabine, Durvalumab
- Where
- 71 sites in United States, Brazil and 12 more
- Volunteers
- 452 people
- Sponsor
- AstraZeneca
HIV Infections
Study to Explore Safety And Tolerability of Fosamprenavir With or Without Ritonavir in Combination With TRIZIVIR or COMBIVIR
Antiretroviral Therapy (ART) naive subjects will be enrolled in this clinical research study to test the safety and tolerability of fosamprenavir with or without ritonavir in combination TRIZIVIR and COMBIVIR.
- Trial name
- NCT00043888
- Testing
- fosamprenavir, COMBIVIR, ritonavir
- Where
- 18 sites in United States, France and 1 more
- Volunteers
- 60 people
- Sponsor
- GlaxoSmithKline
Healthy
Safety and Tolerability of 4 Different Dosage Strengths of BIBW 2992 Tablets to Healthy Male Volunteers
Study to assess pharmacokinetics incl. dose proportionality, safety and tolerability of 4 different dosage strengths of BIBW 2992 tablets (final formulation of 20 mg, 30 mg, 40 mg, 50 mg) administered as single doses to healthy…
- Trial name
- NCT02171767
- Testing
- BIBW 2992 MA2 - single rising dose
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Venous Leg Ulcer, Chronic Non-Healing Cutaneous Wounds
LUT017 Gel for Venous Leg Ulcers and Chronic Non-Healing Skin Wounds in Adults
This research study is investigating a new topical medication called LUT017, which is being developed to help heal chronic skin wounds, particularly those known as venous leg ulcers (VLUs).
- Conditions
- Venous Leg Ulcer, Chronic Non-Healing Cutaneous Wounds, VLU
- Trial name
- NCT07463365
- Testing
- LUT017 gel
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Antoni Ribas
Parkinson Disease
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease
The purpose of this study is to generate evidence of the safety, tolerability, and pharmacokinetics/pharmacodynamics of IV LY4006896 compared with placebo in healthy participants and participants with Parkinson's disease.
- Trial name
- NCT06809400
- Testing
- LY4006896
- Where
- 14 sites in United States, Japan
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Eli Lilly and Company
Allergic Contact Dermatitis
Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis
A Double-blind, Vehicle-controlled Study to Assess the Safety, Tolerability, and Efficacy of Three Weeks of Daily Dermal Application of MRX-6 or steroid on the Treatment of Mild to Moderate Allergic Contact Dermatitis of the Hand…
- Trial name
- NCT00867607
- Testing
- MRX-6, Steroid
- Where
- 2 sites in Israel
- Volunteers
- 13 people
- Sponsor
- Hadassah Medical Organization
Pomalidomide Bioequivalence Study in Healthy Volunteers
Bioequivalence Study Comparing Two Pomalidomide 4 mg Capsule Formulations in Healthy Male Subjects
This study evaluated the bioequivalence and tolerability of a test pomalidomide formulation (Xetrane® 4 mg hard capsule) compared with the reference formulation (Imnovid® 4 mg hard capsule) in healthy male subjects under fasting…
- Trial name
- PRO-BEQ-PMD-00 (NCT07694011)
- Testing
- Xetrane® (Pomalidomide) 4 mg Hard Capsule, Imnovid® (Pomalidomide) 4 mg Hard Capsule
- Where
- Chile
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Knight Therapeutics (USA) Inc
Neoplasm Metastasis, Gastric Cancer
Safety Study of GC1118 (Recombinant Human Anti-EGFR Antibody) in Patients With Advanced Solid Cancer
The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous (IV) infusion to patients with stage IV…
- Conditions
- Neoplasm Metastasis, Gastric Cancer, Colorectal Cancer
- Trial name
- NCT02352571
- Testing
- GC1118
- Where
- South Korea
- Volunteers
- 72 people
- Sponsor
- Green Cross Corporation
Healthy Volunteers
A Combined SAD and MAD Study to Investigate the Safety, Tolerability and Pharmacokinetic Profile of IFB-088
This is the first study of single and multiple doses of IFB-088 in human subjects. The current study is designed to assess in the first part, the safety, tolerability, plasma and urine pharmacokinetics (PK) of single oral doses…
- Trial name
- NCT03610334
- Testing
- IFB-088 (2.5-60.0mg) oral capsule, IFB-088 (15.0-50.0mg) oral capsule
- Where
- 2 sites in France
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- InFlectis BioScience