A Randomized, Single-center, Double-blind, Placebo-controlled, First-in-human Trial With Single and Multiple Ascending Doses to Determine Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GRT7041 in Healthy Participants.
Sponsor study identifier
interventional
70
1 country
1
Study Start
January 14, 2026
Actual (reported)Primary Completion
August 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this trial is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of GRT7041 in healthy male and female (Women of non-childbearing potential) participants. The trial duration will be up to approximately 6 weeks for participants in Part 1 (Single ascending dose \[SAD\]), except for participants taking part in the food effect cohort SAD3 where the trial duration will be up to approximately 8 weeks. The trial duration will be up to approximately 7 weeks in Part 2 (Multiple ascending dose \[MAD\]), and the Treatment Period will be up to 14 days (for Part 2). The trial will include a Screening Visit, an in-house stay period and Follow-up (FU) Visit/End-of-Trial (EoT) Visit.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 24, 2025
Actual (reported)December 17, 2025
Actual (reported)January 14, 2026
Actual (reported)August 24, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of participants with Adverse Events
An AE is defined as any unfavorable medical occurrence in a trial participant administered the investigational product. Assessment of the safety and tolerability of GRT7041 after oral single and multiple-dose escalation
Through study completion, an average of 8 Weeks
Number of participants with Serious Adverse Events
A Serious Adverse Event (SAE) is any untoward medical occurrence that, at any dose: * Results in death, is life-threatening, or requires (or prolongs) hospitalization; * Results in persistent or significant disability/incapacity; * Is a congenital anomaly or birth defect; or * Is considered medically significant, requiring intervention to prevent one of the outcomes above. * Investigator judgment applies to other clinically important events that may not be immediately life-threatening but could jeopardize participant safety. Assessment of the safety and tolerability of GRT7041 after oral single and multiple-dose escalation
Through study completion, an average of 8 Weeks
Area Under the Concentration-Time Curve from 0 to 24 hours [(AUC)0-24] [SAD]
Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)
Area Under the Plasma Concentration-Time Curve from Time 0 to the last measurable concentration (t) [AUC0-t] [SAD]
Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)
Area Under the Plasma Concentration-Time Curve from Time 0 extrapolated to infinity (AUC0-inf ) [SAD]
Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)
Maximum Observed Plasma Concentration (Cmax) [SAD]
Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)
With up to five cohorts SAD1 to SAD5 (n = 40). To be conducted in adult males and WONCBP
With up to three cohorts, MAD1 to MAD3 (n = 30) dosed once daily (QD) for a period of 14 days. To be conducted in adult males only.
Single ascending doses
Placebo to match GRT7041 dose strength
New Zealand Clinical Research (NZCR)
Christchurch, 8011, New Zealand
First Submitted
November 24, 2025
First Posted
December 17, 2025
Study Start
January 14, 2026
Actual (reported)Primary Completion
August 24, 2026
Estimated (date passed)Time to Reach Maximum Observed Plasma Concentration (Tmax) [SAD]
Day 1 to Day 4 (Pre-dose, 0 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour 1.5 hours, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 15 hours, 18 hours, 24 hours, 30 hours, 36 hours, 48 hours, 72 hours) and Day 10 (240 hours)
Solution
Multiple ascending doses
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
August 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 20, 2026
Record last verified: 2025-12
Information available on the Grünenthal Group Web Site (see URL below for details); according to the European Federation of Pharmaceutical Industries and Associations (EFPIA) Data Sharing Principles.
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Source: ClinicalTrials.gov.
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