NM26-2198 50 mg for Atopic Dermatitis

California Clinical Trials Medical Group (CCTMG) managed by Parexel, Glendale, CA
Atopic DermatitisNM26-2198 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests the safety, side effects, and how the body handles a drug given by injection to people with moderate to severe Alzheimer's.

Eligible Conditions
  • Atopic Dermatitis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1

Study Objectives

2 Primary · 28 Secondary · Reporting Duration: Pre-dose on Day 1 through Day 85

Day 57
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [SAD]
Day 85
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) [MAD]
Day 57
Mean ADA titers [SAD]
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [SAD]
Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [SAD]
Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [SAD]
Pharmacokinetics of NM26-2198: Clearance (CL/F) [SAD]
Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [SAD]
Pharmacokinetics of NM26-2198: Half-Life (t1/2) [SAD]
Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [SAD]
Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [SAD]
Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [SAD]
Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [SAD]
Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [SAD]
Day 85
Mean ADA titers [MAD]
Percentage of subjects developing treatment-emergent anti-drug antibodies (ADAs) [MAD]
Percentage of subjects developing treatment-enhanced anti-drug antibodies (ADAs) [MAD]
Pharmacokinetics of NM26-2198: Accumulation Ratio for AUCtau (Racc,AUCtau) [MAD]
Pharmacokinetics of NM26-2198: Accumulation Ratio for Cmax (Racc,cmax) [MAD]
Pharmacokinetics of NM26-2198: Area Under the Curve During the Dosing Interval (AUCtau) [MAD]
Pharmacokinetics of NM26-2198: Clearance (CL/F) [MAD]
Pharmacokinetics of NM26-2198: Estimated Total Exposure (AUCinf) [MAD]
Pharmacokinetics of NM26-2198: Half-Life (t1/2) [MAD]
Pharmacokinetics of NM26-2198: Last Area Under the Curve (AUClast) [MAD]
Pharmacokinetics of NM26-2198: Peak Concentration (Cmax) [MAD]
Pharmacokinetics of NM26-2198: Terminal Elimination Rate (λz) [MAD]
Pharmacokinetics of NM26-2198: Time of Peak Concentration (Tmax) [MAD]
Pharmacokinetics of NM26-2198: Time-Averaged Concentration (AUC%extrap) [MAD]
Pharmacokinetics of NM26-2198: Trough Concentration (Ctrough) [MAD]
Pharmacokinetics of NM26-2198: Volume of Distribution (Vz/F) [MAD]

Trial Safety

Trial Design

8 Treatment Groups

NM26-2198 50 mg
1 of 8
NM26-2198 600 mg
1 of 8
NM26-2198 10 mg
1 of 8
NM26-2198 150 mg
1 of 8
NM26-2198
1 of 8
NM26-2198 300 mg
1 of 8
NM26-2198 400 mg
1 of 8
Placebo
1 of 8

Experimental Treatment

Non-Treatment Group

102 Total Participants · 8 Treatment Groups

Primary Treatment: NM26-2198 50 mg · Has Placebo Group · Phase 1

NM26-2198 50 mg
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
NM26-2198 600 mg
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
NM26-2198 10 mg
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
NM26-2198 150 mg
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
NM26-2198
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
NM26-2198 300 mg
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
NM26-2198 400 mg
Biological
Experimental Group · 1 Intervention: NM26-2198 · Intervention Types: Biological
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-dose on day 1 through day 85

Who is running the clinical trial?

Numab Therapeutics AGLead Sponsor
1 Previous Clinical Trials
406 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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Frequently Asked Questions

What implications does the use of NM26-2198 10 mg have for human health?

"Unsurprisingly, NM26-2198 10 mg earned a score of 1 due to its lack of safety and efficacy data associated with Phase 1 trials." - Anonymous Online Contributor

Unverified Answer

What is the size of the cohort receiving this clinical trial treatment?

"Right. Clinicaltrials.gov offers evidence that this medical trial, which was first announced on May 10th 2023, is actively enrolling participants. This trial seeks to enrol 102 patients from one clinical centre." - Anonymous Online Contributor

Unverified Answer

Are there any remaining vacancies to be filled for this research effort?

"Yes, the clinical trial is currently accepting participants. Initially posted in May 10th 2023 and recently edited on May 5th 2023 , this study needs 102 volunteers to be recruited from one medical site." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.