Multiple Dose Study to Determine Safety and Tolerability of ESK-001 in Healthy Participants

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Alumis Inc

Disqualifiers: Prior ESK-001 exposure, hypersensitivity, others

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

49 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called ESK-001 on healthy people to see if it is safe and well-tolerated. Researchers will study how the drug moves through the body and what effects it has.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it might imply that participants should not be on any regular medications. Please check with the trial coordinators for specific guidance.

What safety data exists for the treatment ESK-001 and its variants?

The available research does not provide specific safety data for ESK-001 or its variants. However, it highlights the importance of safety pharmacology in predicting adverse effects before clinical trials and the need for consistent methods in assessing adverse reactions. ^{1 2 3 4 5}

Research Team

Mark Bradley

Principal Investigator

Alumis Inc

Eligibility Criteria

Inclusion Criteria

Participant is a man or woman between the ages of 18 and 60years, inclusive, at the Screening Visit

Participant is healthy as determined by medical history, physical examination, vital signs, and routine laboratory parameters

Other inclusions as specified in the protocol

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ESK-001 or placebo for 14 days to assess safety, tolerability, pharmacokinetics, and pharmacodynamics

2 weeks

Daily visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ESK-001
• Placebo

Participant Groups

Group I: Experimental Drug ESK-001 Experimental Treatment 1 Intervention

Experimental Drug ESK-001

Group II: Placebo Placebo Group 1 Intervention

Placebo for ESK-001

Who Is Running the Clinical Trial?

Alumis Inc

Lead Sponsor

Trials

9

Recruited

4,200+

Findings from Research

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

The review of clinical research data from 1977 to 2011 highlights significant inconsistencies in how adverse reactions (AR) to drugs are assessed, which can affect the reliability of safety information provided to patients.

To improve the safety profiles of medications, the authors advocate for the establishment of a common European standard for the structured assessment of adverse reactions in clinical research, as no such standard currently exists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Assessing adverse reactions in clinical trials]. Harnisch, S., Schade-Brittinger, C., Rief, W.[2013]

In a review of 113 placebo-controlled randomized clinical trials published in 2016, only 19.5% of journal articles and 45.1% of study protocols provided descriptions of placebo contents, highlighting a significant lack of transparency in clinical trial reporting.

None of the journal publications explained the rationale for the choice of placebo ingredients, which raises concerns about the potential effects of active placebos on trial outcomes and complicates the assessment of the safety and efficacy of experimental interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. Hong, K., Rowhani-Farid, A., Doshi, P.[2023]

Safety pharmacology (SP) is crucial in drug development, helping to identify potential adverse effects of new chemical entities (NCEs) before they reach clinical trials, as outlined in ICH S7A and S7B guidelines.

Emerging practices in SP, such as frontloading and the use of biomarkers, can improve the assessment of drug safety by providing deeper mechanistic insights into potential adverse effects on major organ systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety pharmacology--current and emerging concepts. Hamdam, J., Sethu, S., Smith, T., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

[Assessing adverse reactions in clinical trials]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. [2023]

4. England pubmed.ncbi.nlm.nih.gov

A preclinical secondary pharmacology resource illuminates target-adverse drug reaction associations of marketed drugs. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Safety pharmacology--current and emerging concepts. [2022]