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YOLT-201

Phase 1

Transthyretin Amyloidosis Polyneuropathy | Small molecule | Neurology |cbdMD, Inc.|Last Updated: Aug 6, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

YOLT-201 · 1 trial · 2 indications

Phase 1 1
NCT06539208A Phase I/IIa,Open-label, Single Ascending Dose and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YOLT-201 in Patients With Transthyretin Amyloidosis Polyneuropathy (ATTR-PN) or Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)Transthyretin Amyloidosis Polyneuropathy
RECRUITING31 Analytics
PHASE1RECRUITING
A Phase I/IIa,Open-label, Single Ascending Dose and Dose-expansion Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of YOLT-201 in Patients With Transthyretin Amyloidosis Polyneuropathy (ATTR-PN) or Transthyretin Amyloidosis Cardiomyopathy (ATTR-CM)
Transthyretin Amyloidosis PolyneuropathyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
through week 104

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
YOLT-201EXPERIMENTAL -

Interventions

NameTypeDescription
YOLT-201DRUGInfusion of YOLT-201 at Day 1
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Age 18 - 80 years old (including the critical values), regardless of gender; 2. Body weight at the time of screening is between 40 - 90kg (including the critical values); 3. TTR gene mutation is confirmed by genetic testing; 4. At the time of screening, the following laborato...

Countries:China
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Frequently asked questions about YOLT-201

What is YOLT-201 used for?

YOLT-201 is an investigational small molecule being developed for the treatment of transthyretin amyloidosis polyneuropathy (ATTR-PN). It is also being studied in patients with transthyretin amyloidosis cardiomyopathy (ATTR-CM). The drug is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes YOLT-201?

YOLT-201 is being developed by cbdMD, Inc., a company traded on the stock market under the ticker YCBD. The company is conducting clinical trials of YOLT-201 in patients with transthyretin amyloidosis polyneuropathy and transthyretin amyloidosis cardiomyopathy.

What phase is YOLT-201 in?

YOLT-201 is in Phase 1 clinical development. It is currently being evaluated in an open-label, single ascending dose and dose-expansion study. The drug is investigational and has not received FDA approval or any other regulatory approval for commercial use.

What clinical trials is YOLT-201 in?

YOLT-201 is being studied in a Phase I/IIa clinical trial with the identifier NCT06539208. This open-label, uncontrolled study is recruiting 31 participants in China to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of YOLT-201 in patients with transthyretin amyloidosis polyneuropathy or transthyretin amyloidosis cardiomyopathy.

Is YOLT-201 the same as any other drug?

No alternative names for YOLT-201 have been disclosed. The drug is identified solely by its code name YOLT-201 in clinical trial registrations and company communications. It is a distinct investigational compound being developed by cbdMD, Inc.