Trials Sponsors Conditions Drugs Pricing

Conditions

Malaria

Keywords

Malaria

Outcome Measures

Primary Outcomes (1)

Incidence and Severity of Adverse event of ZY-19489 administered to healthy subjects.
Common Terminology Criteria for Adverse Event (CTCAE) (Version 5.0 or higher) system will be used for reporting and grading
For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30

Secondary Outcomes (13)

Area under the curve from the time of dosing to the last measurable concentration (AUC0-t)
For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Cmax
For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
To assess the effect of ZY-19489/ZY-20486on the QTc interval (concentration/QTc modelling).
For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
AUC0-∞
For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
Tmax
For Part 1 : Baseline to Day 28 and For Part 2 : Baseline to Day 30
+8 more secondary outcomes

Study Arms (2)

ZY19489 Capsule

EXPERIMENTAL

Experimental study drug

Drug: ZY19489 Capsule

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo Capsule

Interventions

ZY19489 CapsuleDrug

Two part study with single and multiple dose

ZY19489 Capsule

Placebo CapsuleDrug

Two part study with single and multiple dose

Placebo

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive who will be contactable and available for the duration of the trial and up to 2 weeks following the End of Study visit.
Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18.5 to 30.0 kg/m2 (Both inclusive). BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in meters.

Sponsors & Collaborators

Zydus Lifesciences Limited
Industrylead

Study Sites (1)

Zydus Research Centre

Ahmedabad, Gujarat, 382213, India

MeSH Terms

Conditions

Malaria

Interventions

ZY-19489

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

Dr Deven Parmar, MD
Zydus Therapeutics Inc.
STUDY CHAIR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2021

First Posted

January 25, 2022

Study Start

August 25, 2021

Actual (reported)

You may not qualify if:

Haematology, clinical chemistry or urinalysis results at screening that are outside of clinically acceptable laboratory ranges, and are considered clinically significant by the Investigator.
Participation in any investigational product study within the 12 weeks preceding IMP administration.
History or presence of diagnosed (by an allergist/immunologist) or treated (by a physician) food or known drug allergies, or history of anaphylaxis or other severe allergic reactions. Subjects with seasonal allergies/hay fever or allergy to animals or house dust mite that are untreated and asymptomatic can be enrolled in the study based on Investigator's discretion.
Presence of current or suspected serious chronic diseases such as cardiac or autoimmune disease (HIV or other immuno-deficiencies), insulin-dependent and non-insulin dependent diabetes, progressive neurological disease, severe malnutrition, acute or progressive hepatic disease, acute or progressive renal disease, porphyria, psoriasis, rheumatoid arthritis, asthma (excluding childhood asthma, or mild asthma with preventative asthma medication required less than monthly), epilepsy, or obsessive-compulsive disorder.
History of malignancy of any organ system treated or untreated, within 5 years of screening, regardless of whether there is evidence of local recurrence or metastases.
Subjects with history of schizophrenia, bi-polar disease, psychoses, disorders requiring lithium, attempted or planned suicide, or any other severe (disabling) chronic psychiatric diagnosis.
Subjects who have received psychiatric medications within 1 year prior to enrolment, or who have been hospitalized within 5 years prior to enrolment for either a psychiatric illness or due to danger to self or others.
History of more than one previous episode of major depression, any previous single episode of major depression lasting for or requiring treatment for more than 6 months, or any episode of major depression during the 5 years preceding screening.
History of recurrent headache (e.g. tension-type, cluster or migraine) with a frequency of ≥2 episodes per month on average and/or severe enough to require medical therapy, during the 5 years preceding screening.
Presence of clinically significant infectious disease or fever (e.g. sublingual temperature ≥38.5°C) within the 14 days prior to enrollment.
Evidence of acute illness within the 4 weeks prior to screening that the Investigator deems may compromise subject safety.
Significant inter-current disease of any type, in particular liver, renal, cardiac, pulmonary, neurologic, gastrointestinal, rheumatologic, or autoimmune disease by history, physical examination, and/or laboratory studies including urinalysis.
Subject has a clinically significant disease or any condition or disease that might affect drug absorption, distribution or excretion (e.g. gastrectomy, diarrhoea).
Blood donation of any volume within 1 month before IMP administration, or participation in any research study involving blood sampling (more than 450 mL/unit of blood), or blood donation to blood bank during the 12 weeks prior to IMP administration.
Medical requirement for intravenous immunoglobulin or blood transfusions within 3 months prior to enrollment.
+22 more criteria

A Study Of Zy-19489 Administered Via Oral Route To Investigate The Safety, Tolerability And Pharmacokinetics In Healthy Adult Human Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

ZY19489 Capsule

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

Primary Completion

Study Completion

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (2)

ZY19489 Capsule

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations